The proper selection of safety equipment is contingent upon the type of materials that are being handled. Class II Biological Safety Cabinets are sometimes utilized for processing sterile drugs when working in a cleanroom environment. However, Compounding Aseptic Containment Isolators (CACIs) provide the most comprehensive solution for meeting USP 825 requirements and are an ideal alternative to a costly dedicated cleanroom. In CACIs all work occurs inside a closed, pressurized workspace, which is accessible only via a sealed glove system. For the preparation of radiopharmaceuticals there are specialized Compounding Aseptic Containment Isolators known as a Radiopharmacy Isolators.
The Radiopharmacy Isolator is a Containment Primary Engineering Control (C-PEC) designed specifically for handling radiopharmaceuticals. It can also be considered a SPRA when not placed in a cleanroom. These units are lead shielded to protect the operator and provides ISO 5/class 100 air to protect the product. Lead shielding is utilized to attenuate radiation in certain applications because of its high density. Therefore, these lead lined Compounding Aseptic Containment Isolators are a core safety component in the radiopharmacy.
The Radiopharmacy Isolator must be properly designed and engineered to provide maximum protection for the operator, work in progress and the surrounding environment. Germfree’s shielded isolator functions as a Glovebox while operating under negative pressure to meet NIOSH recommendations. The unit is fully compliant with USP 825 regulations for use outside of a cleanroom, adding flexibility to operations that process sterile radiopharmaceuticals.
The Radiopharmacy Isolator has a unidirectional laminar airflow system that maintains ISO 5/Class 100 air quality. The work area of the unit is continuously bathed with unidirectional HEPA-filtered air to protect the product from contamination. This also filters any particulates that are generated by the manipulation of materials. Germfree’s Radiopharmacy Isolator meets or exceeds ISO 14644-1 standard for Class 100 air quality under dynamic conditions.
Due to lack of universal manufacturing standards, it is imperative to select radiopharmaceutical compounding equipment that is engineered to the rigorous demands of working with sterile radiological materials. Germfree’s Radiopharmacy Isolator incorporates ¼” lead shielding to protect the operator from all products being manipulated in the Glovebox/Isolator. Units must undergo a comprehensive testing process to assure they meet the requirements specific to working with radiopharmaceuticals.
Isolators that are suitable for radiopharmaceutical compounding incorporate a range of features, capabilities and technical specifications. These may include:
- ¼” Standard Lead Shielding located in the back, sides, bottom and front of the work area; Lead is encapsulated between the interior and exterior stainless steel panels of the unit
- Provides USP <825> compliance as a SRPA without the need for complex pharmacy ventilation renovations (No need for ISO Class 7 buffer room)
- The isolator’s filtration system provides 100% HEPA filtration of supply and exhaust air from both the work area and the antechamber to create a fully controlled and contained environment
- Accommodates a range of dose calibrators
- The unit must have work area access controls
- Digital pressure gauge with audible and visual low pressure alarm
- Inward face velocity: 95-100 l.f.p.m. at gloveport opening for added protection
- Glove changes can be made to the unit without breaking containment
- ¼” lead shielding of ergonomically placed sharps and waste tubes container
- The unit’s interior and exterior is constructed of all pharmaceutical grade stainless steel
- All corners in the work area are seamless; the antechamber and work surfaces are designed for ease of user access and cleaning
The large, full view window of the Radiopharmacy Isolator is constructed from 46mm thick leaded acrylic
Antechamber System: Sealed two-door airlock maintains complete environmental separation between the work area and the radiopharmacy; HEPA-filtered purge system eliminates cross-contamination when materials are introduced and removed from the Radiopharmacy Isolator.
Radiopharmaceuticals play an important role in nuclear medicine as diagnostic and therapeutic agents. This specialized field presents certain demands on the professional Radiopharmacist. Proper training, SOPs, best practices, quality assurance standards, facility design and safety equipment are integral to any Radiopharmacy operation. The Radiopharmacy Isolator provides the most comprehensive solution for safely compounding radiopharmaceuticals.
